Investigators are responsible for conducting clinical research in accordance with the following:
The Belmont Report
This report was issued in 1979 and outlines the basic ethical principles and guidelines for research involving human subjects.
Good Clinical Practice
Schulman is in compliance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines for IRBs. For more information about GCP, refer to FDA’s Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance.
Code of Federal Regulations
Code of Federal Regulations (CFR) Title 21 addresses the requirements for conducting clinical research involving human subjects under the oversight of the Food and Drug Administration. For more information, please refer to the following sections of 21 CFR:
- Title 21 Part 50 (Informed Consent)
- Title 21 Part 54 (Financial Disclosure)
- Title 21 Part 56 (Institutional Review Boards)
- Title 21 Part 312 (Investigational New Drug Application)
- Title 21 Part 812 (Investigational Device Exemption)
CFR Title 45 Part 46
U.S. Department of Health & Human Services regulations addresses requirements for conducting research involving human subjects that is federally funded or otherwise obligated to adhere to these regulations (e.g., in accordance to a specific Federalwide Assurance).
CFR Title 40 Part 26
Environmental Protection Agency (EPA) regulations addresses requirements for conducting research involving human subjects that is under the oversight of the EPA.
Food and Drug Regulations Part C, Division 5
Part C, Division 5 of the Health Canada Food and Drug Regulations addresses requirements for conducting clinical research involving human subjects in Canada.
Tri-Council Policy Statement
Tri-Council Policy Statement was published in 1998 by the three major Canadian federal research funding agencies to describe the obligations of institutions, researchers and Research Ethics Boards (REB) in the conduct of research involving human subjects.
Food and Drug Administration (FDA) Information Sheets
FDA Information Sheets are designed to enhance the Code of Federal Regulations by providing guidance on many topics including, but not limited to, recruitment materials, subject compensation, and obtaining informed consent.
Personal Information Protection and Electronic Documents Act (PIPEDA)
PIPEDA describes Canadian regulations regarding personal information including protected health information.